Guidance and Q&As

The Clinical Trials Information System (CTIS) is the online system for the regulatory submission, authorisation and supervision of clinical trials in the European Union and the European Economic Area.

You can find more information on CTIS on our About page

Sponsors must submit initial clinical trial applications from 31 January 2023 under the Clinical Trials Regulation through CTIS. In addition, sponsors must transfer any ongoing trials started under the Clinical Trials Directive to CTIS by 31 January 2025.

If you work for a Member State organisation, please check with your Member State Master Trainer about whether you should use CTIS.

The Clinical Trials Information System (CTIS) is structured in two restricted and secured workspaces (sponsor workspace and authority workspace) and a public website.

Access to the secured CTIS workspaces is possible for any user that has obtained a valid EMA account (for any application managed by the EMA, e.g. SPOR, IRIS, EudraVigilance). If users do not have an EMA account, they will have to register through the self-registration process described below.

The sponsor workspace is accessible to sponsor users (industry and academia) and marketing authorisation applicants. The authority workspace is accessible to Member States' national competent authorities, ethics committees, the European Commission, and the European Medicines Agency (EMA). Access to the public website is possible for any user without the need for registration.

Register your organisation

If your organisation is registered in EMA’s Organisation Management Service (OMS), you can retrieve its details in CTIS to populate applications for clinical trials or your personal profile. If your organisation is not registered yet in the OMS, you should register it via the SPOR data management services first.

Guidance is available on the SPOR website under OMS: Documents.

Choose user-management approach

Sponsors who are new to CTIS should choose between two user-management approaches: organisation-centric or trial-centric.

The organisation-centric approach is designed for sponsors who run clinical trials on a regular basis. It enables the organisation to appoint one or more high-level administrator users to maintain oversight of the roles and access levels of all [CTIS] users within their organisation. In order to follow this approach, your organisation needs to register a high-level administrator user via the EMA Account Management portal.

The trial-centric approach is designed for sponsors who only run clinical trials on an ad-hoc basis. It is the default user-management approach is [CTIS], and is applied automatically when the organisation does not have a registered high-level administrator. Following this approach, user roles and access levels are defined at trial level by the user who creates the initial application.

For more information, see our materials available online:

• Online video: organisation vs trial-centric approach (2:59 mins)
• FAQs: CTIS training programme module 03: User access management (pdf)
• CTIS training material module 03: User access management: Quick guide (pdf)

Register your investigational medicinal products

For newly developed medicines that have not been studied in clinical trials before or authorised in the EU, sponsors need to submit medicine-related information into EMA’s Extended EudraVigilance medicinal product dictionary (XEVMPD).

The information provided for a clinical trial can be submitted in one or more languages. Data and documents can be provided in all the official languages of the European Union (EU). Certain countries in the EU or the Economic European Area (EEA) may require that data is provided in a commonly understood language in the medical field, such as English, or in national language, as provided for in Article 26 of the Clinical Trial Regulation.

A key goal of the Clinical Trials Regulation is transparency for clinical trials data.

All information submitted to CTIS will be made public, unless it is found necessary not to publish it to protect:

• Personal data
• Commercially confidential information, in particular the marketing-authorisation status of a medicine, unless there is an overriding public interest
• Confidential communication between EU/EEA regulators during the assessment
• Supervision of clinical trials by EU/EEA regulators

Find out more about what information is available

Please consult Eudralex volume 10 – clinical trials guidelines, which includes the questions and answers document on the Clinical Trials Regulation, for more information and guidance related to the Clinical Trials Regulation.

Please contact the European Union Member State(s) or the European Economic Area country concerned for your clinical trial application for general guidance on clinical trial assessment processes/decision criteria.

To find the regulatory authority for medicines for human use (also known as national competent authority, or NCA) of a European Union Member State or a European Economic Area, we refer you to the overview on the European Medicines Agency’s (EMA) website.

View national competent authorities

You can find relevant links to training, guidance and reference material on our training page.

Go to the training page

In general, good internet connectivity, some system requirements and some other recommendations which we have listed for you:

Technical requirements for optimal use of CTIS

We recommend you consult our training and guidance to troubleshoot issues with the Clinical Trials Information System (CTIS). If answers cannot be found in these materials, users can make use of the User support service.

Our online modular training programme includes tailored questions and answers (FAQs). We also provide support and reference material to help you work with CTIS.

• Go to the online modular training programme on EMA’s website
• Find support and reference material on EMA’s website

Please consult the Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) version 2 together with its Annex I. The guidance aims to assist sponsors and authorities in fulfilling the transparency obligations set out in the Clinical Trials Regulation. Annex I provides an overview of the expected personal data contained in referenced documents/fields.

Please also refer to the associated Q&A on the protection of Commercially Confidential Information and Personal Data while using CTIS, which included recommendations from the member states and product owners on frequently asked questions.

Please consult the Joint Controllership Arrangement with regards to CTIS and the related Q&A document for more information

The revised CTIS transparency rules became applicable on 18 June 2024 with the launch of a new version of the CTIS public website and of the CTIS secure workspaces. For all clinical trial applications submitted on or after that date:

- It is no longer possible to defer the publication of certain data and documents.

- Data and documents are published according to the established timelines for the trial category, population age and trial phase.

- Publication of documents is focused on key documents of interest.

For an overview of what is published and when, refer to the quick guide for users.

Data on all clinical trial applications submitted before 18 June 2024 is made publicly available in line with the principles and timelines defined in the revised transparency rules. Please note that documents of those trials are not published. Documents contained in subsequent applications of these trials, submitted after 18 June 2024 are published in line with the revised rules; more details are available in the quick guide for users.

Further details on the implementation of the revised rules on trials submitted before go live date of the new public website can be found in section 4 of Q&A on the protection of Commercially Confidential Information and Personal Data while using CTIS.

A video recording of the CTIS Bitesize talk on the transparency rules provides an overview of the changes.

The detailed list of structured data and documents that are subject to publication is specified in documents on CTA fields and Notifications. In addition, Table I and Table II of the Annex I to the Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) provide an overview of the types of data and documents submitted to CTIS that are subject to publication, in line with the revised CTIS transparency rules. Information is also provided on the disclosure timelines, which mainly depend on the trial category, the trial phase, and the trial population age. The trial category is chosen by the sponsor when filling in the ‘form’ section of the application, based on definitions provided in table V of Annex I.